Dietary Supplements A Framework for Evaluating Safety (2005) / Chapter Skim
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Executive Summary
Executive Summary
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determine what is unsafe without requiring that specific information on safety be presented by manufacturers prior to marketing or that manufacturers submit to the FDA any reports they have received on serious adverse events associated with dietary supplement use -- serve to make the safety regulation of dietary supplements a sizeable challenge. THE COMMITTEE'S TASK FDA must approach evaluating the safety of dietary supplement ingredients in a manner that is cost effective and science based within this regulatory environment.
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, FDA has wrestled with the most appropriate approach to regulating dietary supplements and several attempts have been met with resistance by industry as well as by segments of the public. In 1958, the Food Additives Amendment to the FDCA defined food additives and provided that they must undergo a premarket approval process unless they were considered to be generally recognized as safe (GRAS)
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I The Process Three major components comprise the process: · Signal detection · Initial review of available information · Integrative evaluation 2The term manufacturer is used for simplicity, but the statutes related to dietary supplements refer to both manufacturers and distributors, which may or may not be the same for a given dietary supplement ingredient or product.
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respond with no objection, (3) not respond Postmarket No No No reporting or surveillance by industry required Burden of FDA must demonstrate FDA must demonstrate FDA must proof of significant or significant or demonstrate safety unreasonable risk of unreasonable risk of that food is harm to remove harm to prevent injurious to product from market product from being health to marketed remove product from market a DSHEA = Dietary Supplement and Health Education Act of 1994.
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a rule requiring marketers of food developed through biotechnology to notify the agency at least 120 days before commercial distribution and to provide information to demonstrate that the product is as safe as its conventional counterpart. f While the final regulations for the notification procedure are not yet published, the interim policy outlined by FDA in the proposed regulations invites interested persons who determine that a substance is GRAS to notify FDA of such GRAS determinations as described in the proposed regulation 21 C.F.R.
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. Signal Detection Given the large number of dietary supplement ingredients and that dietary supplements are assumed to be safe in general, it is unlikely that FDA will have the resources or need to evaluate each ingredient uniformly.
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One of the requirements of the study was to develop a framework that would include criteria for how the review of safety of dietary supplements
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8 DIETARY SUPPLEMENTS Signal Detection Proactive Initiation Initial Review Concern Level Lower..............................Higher Integrative Evaluation Gather Data -Categories -Prevalence of Use -Use by Vulnerable Groups MONITOR Draft Monograph TAKE Continue to ACTION Collect Data Integrate Data Use Expert Advisory Committee Concern Level Lower..............................Higher FIGURE ES-1 Diagram of the three components of the Safety Framework: signal detection, identification of level of concern in an initial review, and integrative evaluation, as well as how these components feed into FDA's decision to take action.
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Since it is assumed by DSHEA that dietary supplements are safe, there should be relatively few dietary supplement ingredients that will be categorized as of higher concern after the initial review and thus warrant further examination. This allows FDA to focus its efforts on the few dietary supplement ingredients that are strong candidates for regulation.
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One of the important components of DSHEA was that the public should be educated about dietary supplements. FDA thus has a responsibility to educate consumers about the safety of supplement ingredients, and the public availability of the completed monographs can be an important aspect of the educational process.
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, important considerations that should be factored into evaluations when vulnerable populations consume dietary supplements (Chapter 9) , and considerations for integrating the available data from various sources to weave together the information to determine an overall level of concern (Chapter 10)
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-- Integration of data across different categories of information and types of study design can enhance biological plausibility and identify consistencies, leading to conclusions regarding levels of concern for an adverse event that may be asso ciated with use of a dietary supplement. · Human data -- A credible report or study finding of a serious adverse event in humans raises concern about the ingredient's safety and requires further information gath ering and evaluation; final judgment, however, will require consideration of the totality of the evidence.
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It is important to recognize that for most dietary supplement ingredients it will be difficult, if not impossible, to find optimal information from all data categories. General Principles and Concepts When Considering Data Concentration of Substances at the Sites of Action.
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However, the principles used by the scientific community to determine the risk associated with the consumption or use of various substances, some of which are medical products, should also apply to dietary supplement ingredients, bearing in mind that dietary supplements, by virtue of DSHEA, have been assumed to be safe, but have not been required to be proven safe. Thus, the appropriate scientific standard to be used to overturn this basic assumption of safety is to demonstrate significant or unreasonable risk, not prove that an ingredient is unsafe.
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· A prospective, systematic monitoring and tracking mechanism for di etary supplement ingredients should be maintained and refined. A prospective, systematic method for recording and monitoring the history of safety issues of specific dietary supplements is necessary to implement the Framework so that FDA can evaluate the safety of dietary supplement ingredients.
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Reports of adverse events are an important source of information by which FDA becomes aware of potential risks to public health from exposure to dietary supplement ingredients. It has been estimated that FDA receives reports of less than 1 percent of all adverse events associated with dietary supplements.
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Thus experiments and studies to address safety issues will, in most cases, be initiated by FDA or other federal agencies. BARRIERS TO EVALUATING THE SAFETY OF DIETARY SUPPLEMENTS Through the process of developing the Framework to evaluate the safety of dietary supplement ingredients, a number of legal and regulatory barriers were identified that hamper FDA's ability to protect the public
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The constraints imposed on FDA with regard to ensuring the absence of unreasonable risk associated with the use of dietary supplements make it difficult for the health of the American public to be adequately protected.
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